Replies to post #110490 on Avid Bioservices Inc (CDMO)

[EYEBUYSTOX]

Fascinating FTM.

If a drug that doubles MOS in 2nd line NSCLC over historic averages (even with a coding error), owned by a company that already has its own manufacturing subsidiary doesn't apply for breakthrough designation, I'd love to hear the reason why they did not. It almost fits Bavi perfectly. Perhaps a pending breakthrough application was the reason for the harsh language in the September PR. I could see this as a reason a partnership would be delayed. $X if approved as a breakthrough, $Y if not. All IMO.

[drragmop]

I haven't read whether or not 'breakthrough' approval carries with it the same rights to use a drug off-label that ordinary approval does. I somehow doubt that it does.

But once we have regular approval for any indication, it seems to me that the oncology community may not care what BP does, or thinks, about Bavi. Assuming the safety profile holds up and a reasonable price, we may see Bavi used as an adjunct or even solo therapy all over the place.

Sort of like the way the alternative energy industry is exploding under our feet.